Passionate, talented, exuberant and dedicated all- round professional, MD with three year of professional experience in the medical field,one year specialization in internal medicine and one year specialization in oncology.Working as a Sr CRA, my medical background is giving me an advantage to monitor studies for almost all indications and has proven to be a winning combination so far, especially in very important fields of the monitoring tasks like safety, detection of AE and SAE.
MD, Senior CRA
Since February 2011
As a Country Site Start-up Regulatory specialist (SSURS) i am responsible for preparing, submitting and following up on initial and follow up submissions to IRB and MOH and other submissions required in Macedonia, within contracted timelines and budget, in accordance with the local regulatory requirements and sound technical principles, including the creation and modification of documentation required for approval.I also ensure importation and exportation requirements are met for IP and any other clinical trial supplies needed for the trial in my country.I provide review and translation in local language of the clinical supply labeling to ensure it meets local regulatory requirements. I also insure that the Insurance certificates, country specific informed consent form and any other subject documentation adheres to the country requirements. As a CRA - Management and monitoring of the Clinical trial, servicing as a primary point of contact for all operational and monitoring related activities Performing site selection and qualification, site initiation, monitoring, study close out, Supporting regulatory filling (submissions to the EC/CA, SAE reporting with regulatory and PI) Managing study files, performing source data verification Monitoring of the drug and Clinical Supplies. As a PV associate i ensure reporting/submission/ distribution of safety reports/updates/information to local Health Authorities (HA) according to regulatory requirements.
MD (Medical Doctor)October 2008 --- June 2010
MD (Medical Doctor)March 2006 --- November 2006
AdaptabilityAnalytical thinkingAttention to detailCommunicativeCharmDependabilityEfficiencyIndependenceProactivityResponsibilitySelf-confidenceResult Oriented
Diabetes NegotiationAdverse Events (AE)Cancer ResearchClinical monitoringClinical Trial Management System (CTMS)Clinical trialseCRFDrug Safety and PharmacovigilanceEmergency medicineEndocrinologyEnglishEthics submission and approval processFamily practiceGermanGood Clinical Practice (GCP)Healthcare ManagementInformed Consent DocumentsInternal medicineIVRS
Skills and Expertise
Interact with physicians Monitor a clinical studyAct as the main line of communication between the sponsor and the investigatorAssist study siteWork under specific instructionsWork cross-functionallyWork collaboratively with the other members of the clinical research team Verify data
Dr of Medicine in from University St Cyril and Methodius in 2004
Training and Certification
Good Clinical Practice (ICH-GCP) in 0000 Certification
Good Clinical Practices in 0000 Certification
ISO 14155:2011 in 0000 Certification